Project Outline:

• Synertec provided its validation methodology, based on the ‘GAMP4 V Model’ for automated systems to devise a validation strategy. The strategy ensured compliance with GMP, FDA 21 CFR Part 11 and Part 820 regulations, as well as the client’s specific administrative, operational and quality requirements. The strategy used a risk-based approach which focused on identifying system functionality which had the potential to affect product quality, data integrity or data security, and implementing risk mitigation strategies where necessary.

• Synertec devised a validation strategy for the validation of an ‘in-house built’ interface between the Trackwise application and the company’s ERP system. The interface was not included in the initial project scope however Synertec’s flexibility and client-focused attitude enabled the Validation Master Plan to be amended and the interface validated along with the Trackwise application with minimal impact on project cost and timeline.

• Synertec proactively managed communication around the various validation activities and the surrounding relationships.

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